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Clinical Trials in the UK / NCT05952037
Active, not recruiting Phase 2

A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia

NCT05952037 · tracked via the Priya Life Science UK tracker
Sponsor
BeOne Medicines
Phase
Phase 2
Started
2023-10-23
Last updated
2026-01-02

Condition(s) studied

Waldenstrom MacroglobulinemiaWaldenstrom's Macroglobulinemia RecurrentWaldenstrom's Macroglobulinemia Refractory

Investigational drug(s) / intervention(s)

SonrotoclaxZanubrutinib

Sonrotoclax: Administered orally as a tablet.

Zanubrutinib: Administered orally as a capsule.

Study summary

This study will evaluate the safety and efficacy of the BCL2 inhibitor sonrotoclax (BGB-11417) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) and in combination with zanubrutinib in adult participants with previously untreated WM.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Clinical and definitive histologic diagnosis of WM. * Meeting ≥ 1 criterion for treatment according to consensus panel criteria from the 2nd International Workshop on Waldenström's Macroglobulinemia (IWWM). * For Cohorts 1-3, refractory or relapsed disease at study entry unless participants had intolerance to the most recent therapy. Refractory disease is defined as not attaining at least a major response, or progressing while on or within 6 months of completing therapy. Relapsed disease is defined as attaining at least a major response to therapy and meeting the criteria for disease progression beyond 6 months after completing therapy. * For Cohort 4, patients must not have received prior therapy for WM (except for plasmapheresis). * Adequate organ function. Exclusion Criteria: * Central nervous system (CNS) involvement by WM. * Transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma. * History of other malignancies ≤ 2 years before study entry. * Uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy that was completed ≤ 14 days before the first dose of the study drug. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (72)

FacilityCityRegionStatus
City of Hope National Medical Center Duarte California
Colorado Blood Cancer Institute Denver Colorado
Medstar Georgetown University Hospital Washington D.C. District of Columbia
University of Miami Miami Florida
Northwestern Medicine Cancer Center Warrenville Illinois
Mission Cancer and Blood Waukee Iowa
University of Maryland Greenebaum Comprehensive Cancer Center Baltimore Maryland
Dana Farber Cancer Institute Boston Massachusetts
Mayo Clinic Rochester Rochester Minnesota
Hattiesburg Hematology and Oncology Clinic Hattiesburg Mississippi
Memorial Sloan Kettering Cancer Center Mskcc New York New York
Atrium Health Levine Cancer Institute (Lci) Charlotte North Carolina
Ohio State University Comprehensive Cancer Center Columbus Ohio
Ut Southwestern Medical Center Dallas Texas
Huntsman Cancer Institute Salt Lake City Utah
Virginia Commonwealth University Massey Cancer Center Richmond Virginia
University of Washington Seattle Washington
Concord Repatriation General Hospital Concord New South Wales
Genesiscare North Shore St Leonards New South Wales
Princess Alexandra Hospital Woolloongabba Queensland
Flinders Medical Centre Bedford PK South Australia
Monash Health Clayton Victoria
St Vincents Hospital Melbourne Fitzroy Victoria
Linear Clinical Research Nedlands Western Australia
Royal Perth Hospital Perth Western Australia
Cross Cancer Institute Edmonton Alberta
Lions Gate Hospital Chemotherapy Clinic North Vancouver British Columbia
Qeii Health Science Center Halifax Nova Scotia
Princess Margaret Cancer Centre Toronto Ontario
The First Affiliated Hospital of Xiamen University Xiamen Fujian
Guangdong Provincial Peoples Hospital Guangzhou Guangdong
Henan Cancer Hospital Zhengzhou Henan
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei
Yancheng First Peoples Hospital Yancheng Jiangsu
Shengjing Hospital of China Medical Universityshenbei Branch Shenyang Liaoning
The Affiliated Hospital of Qingdao University Branch South Qingdao Shandong
Affiliated Zhongshan Hospital of Fudan University Shanghai Shanghai Municipality
The Third Peoples Hospital of Datong Datong Shanxi
Institute of Hematology and Hospital of Blood Disease Tianjin Tianjin Municipality
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang

+ 32 more sites — see the full list on the official registry below.

On this site

📄 Brukinsa (zanubrutinib) drug profile →

More BeOne Medicines trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05952037 on ClinicalTrials.gov ↗ ← All trials in the UK